An observational study in Acute Lung Injury, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-25.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational
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Among 59 studies in Acute Lung Injury with a site in China — 20 open to participants now, 20 under way, 1 of them phase 3. Acute Lung Injury · China.
Among the 59 studies in Acute Lung Injury with a site in China, this one is the 18th largest by enrollment of the 28 observational ones that give a count, is one of 5 that started in 2017, is one of 28 observational ones, and was the 16th registered.
382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.
Browse Acute Lung Injury studies →20 of the 59 studies in Acute Lung Injury with a site in China are open now. Recruiting first, the newest first:
Shanghai Zhongshan Hospital · Sites in China
Ages 18–80
Peking Union Medical College Hospital · Sites in China
Ages 18+
Southeast University, China · Sites in China, Korea, Republic of, Taiwan
Ages 19–90
Peking Union Medical College Hospital · Sites in China
Ages 18–75
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 45 Acute Lung Injury studies recruiting now, 25 (56%) set no upper age limit and 8 (18%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 7 · Phase 3 1 · Phase 4 1
First in 2006; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 100 across 131 observational studies indexed under Acute Lung Injury.
Median enrollment 60 across the 31 interventional studies, 103 across the 28 observational. Of the 20 that completed or were terminated, 3 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 59 have an industry lead sponsor. The 10 most frequent:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine has 4 studies filed under Acute Lung Injury — fewer than ten, so there is no comparison to draw.
8 of the studies in Acute Lung Injury with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07342205Phase 3Shanghai University of Traditional Chinese MedicineA Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation | 2027-06 |
| NCT07558538Shanghai Zhongshan HospitalA Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome | 2026-11-30 |
| NCT07307066Peking Union Medical College HospitalReal-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study) | 2026-12-30 |
| NCT07477951Yongtao SunThe Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications | 2026-12-31 |
| NCT06696638XiaoJing Zou,MDPhysiological Effects of Lung Impedance Tomography-Guided and Plat Pressure-Guided Phigh During APRV in Patients With ARDS | 2026-12-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 59 studies in Acute Lung Injury with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
As novel agonists of Wnt/β-catenin signaling pathway, R-spondin proteins constitute a class of ligands, including R-spondin 1/2/3/4, functioning through their receptors leucine-rich repeat-containing G-protein coupled receptor (LGR)4/5/6 to enhance Wnt/β-catenin activity. Since Wnt signaling plays pivotal roles in the regulation of many life processes involved in embryogenesis and adulthood, R-spondin proteins also take part in cell proliferation, differentiation and morphogenesis.For example, in the formation of respiratory system，R-spondin 2 is required for normal laryngeal-tracheal and lung morphogenesis，and the lack of R-spondin 1 expression results in the absence of duct side-branching development and subsequent alveolar formation. In addition, R-spondins show protective effect in tissue injury and diseases. R-spondin 1 and R-spondin 3 have been reported to prevent chemotherapy- or radiotherapy-induced mucous membrane lesion. R-spondin 1 attenuates oral mucositis contributed by radiotherapy in mouse models and R-spondin 3 potentiates intestinal regeneration elicited via gastrointestinal toxic effect of chemoradiotherapy treatment. However, whether R-spondin proteins exert salient influence on acute lung injury especially induced by mechanical ventilation is deficient. Therefore, this study aims to ascertain the implication of R-spondin proteins in the pathology of mechanical ventilation induced lung injury through detecting human plasma concentration change of R-spondin 1/2/3/4 after mechanical ventilation and interference effects in mouse model, which is helpful for prevention and treatment of ventilation induced lung injury.
Mechanical ventilation is a critical intervention for patients with acute respiratory failure. However, lung overdistension induced by mechanical ventilation also causes pulmonary endothelial dysfunction. The injurious effect of mechanical stretch on pulmonary endothelium has been implicated in the development of ventilator-induced lung injury, which is characterized by pulmonary inflammation and particularly increased vascular permeability. In addition, the investigators and others have previously shown that mechanical stretch increases cultured lung endothelial monolayer permeability in vitro and promotes lung vascular permeability in mice Thus, elucidating the mechanisms underlying the mechanical stretch-induced lung endothelial barrier dysfunction may provide a novel clinical therapeutic target against ventilator-induced lung injury.
As novel agonists of Wnt/β-catenin signaling pathway, R-spondin proteins constitute a class of ligands, including R-spondin 1/2/3/4, functioning through their receptors leucine-rich repeat-containing G-protein coupled receptor (LGR)4/5/6 to enhance Wnt/β-catenin activity. Since Wnt signaling plays pivotal roles in the regulation of many life processes involved in embryogenesis and adulthood, R-spondin proteins also take part in cell proliferation, differentiation and morphogenesis. For example, in the formation of respiratory system，R-spondin 2 is required for normal laryngeal-tracheal and lung morphogenesis，and the lack of R-spondin 1 expression results in the absence of duct side-branching development and subsequent alveolar formation. In addition, R-spondins show protective effect in tissue injury and diseases. R-spondin 1 and R-spondin 3 have been reported to prevent chemotherapy- or radiotherapy-induced mucous membrane lesion. R-spondin 1 attenuates oral mucositis contributed by radiotherapy in mouse models and R-spondin 3 potentiates intestinal regeneration elicited via gastrointestinal toxic effect of chemoradiotherapy treatment. However, whether R-spondin proteins exert salient influence on acute lung injury especially induced by mechanical ventilation is deficient. Therefore, this study aims to ascertain the implication of R-spondin proteins in the pathology of mechanical ventilation induced lung injury through detecting human plasma concentration change of R-spondin 1/2/3/4 after mechanical ventilation and interference effects in mouse model, which is helpful for prevention and treatment of ventilation induced lung injury.
patients undergo elective surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation
Other: mechanical ventilation
mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cm H2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
Change in Plasma Concentration of R-spondin 1
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin1 concentration. And the outcome was calculated by subtracting the R-spondin1 plasmid concentration of sample A from the R-spondin1 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin1.
Time frame: 3 hours
Change in Plasma Concentration of R-spondin 2
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin2 concentration. And the outcome was calculated by subtracting the R-spondin2 plasmid concentration of sample A from the R-spondin2 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin2.
Time frame: 3 hours
Change in Plasma Concentration of R-spondin3
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin3 concentration. And the outcome was calculated by subtracting the R-spondin3 plasmid concentration of sample A from the R-spondin3 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin3.
Time frame: 3 hours
Change in Plasma Concentration of R-spondin4
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin4 concentration. And the outcome was calculated by subtracting the R-spondin4 plasmid concentration of sample A from the R-spondin4 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin4.
Time frame: 3 hours
| Milestone | Control／Mechanical Ventilation |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin1 concentration. And the outcome was calculated by subtracting the R-spondin1 plasmid concentration of sample A from the R-spondin1 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin1.
| pg/ml | Control／Mechanical Ventilation |
|---|---|
| Change in Plasma Concentration of R-spondin 1 | 1407.4080 ± 1350.7859 |
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin2 concentration. And the outcome was calculated by subtracting the R-spondin2 plasmid concentration of sample A from the R-spondin2 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin2.
| pg/ml | Control／Mechanical Ventilation |
|---|---|
| Change in Plasma Concentration of R-spondin 2 | -2.1830 ± 35.3601 |
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin3 concentration. And the outcome was calculated by subtracting the R-spondin3 plasmid concentration of sample A from the R-spondin3 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin3.
| pg/ml | Control／Mechanical Ventilation |
|---|---|
| Change in Plasma Concentration of R-spondin3 | -2.8956 ± 30.2781 |
The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin4 concentration. And the outcome was calculated by subtracting the R-spondin4 plasmid concentration of sample A from the R-spondin4 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin4.
| pg/ml | Control／Mechanical Ventilation |
|---|---|
| Change in Plasma Concentration of R-spondin4 | -269.8598 ± 1230.6612 |
Collected over 3 hours Explanation: The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control／Mechanical Ventilation | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Event | Control／Mechanical Ventilation |
|---|---|
| 0General disorders | 0/52 |
| Age, Categorical(Participants) | Control／Mechanical Ventilation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 52 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Control／Mechanical Ventilation |
|---|---|
| Female | 14 |
| Male | 38 |
| Race (NIH/OMB)(Participants) | Control／Mechanical Ventilation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 52 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Control／Mechanical Ventilation |
|---|---|
| China | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Sep 2017 to primary completion in Oct 2017, 0 months.
Results were first posted in Jul 2019, 1 year 9 months after primary completion.
Of 41 non-industry observational studies under Acute Lung Injury, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 0 months is below that.
Counting every sponsor, half of 46 studies reached it within 18 months; a quarter within 8 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →